WHO: World Malaria Report 2013
http://www.who.int/entity/malaria/publications/world_malaria_report_2013/report/en/index.html
Number of pages: 284
Publication date: 2013
Languages: English (summaries in French and Spanish)
ISBN: 9 789241 56469 4Media Release Excerpt

11 December 2013 | Geneva/Washington DC – Global efforts to control and eliminate malaria have saved an estimated 3.3 million lives since 2000, reducing malaria mortality rates by 45% globally and by 49% in Africa..

…The large majority of the 3.3 million lives saved between 2000 and 2012 were in the 10 countries with the highest malaria burden, and among children aged less than 5 years – the group most affected by the disease. Over the same period, malaria mortality rates in children in Africa were reduced by an estimated 54%.

…In 2012, there were an estimated 207 million cases of malaria (uncertainty interval: 135 – 287 million), which caused approximately 627 000 malaria deaths (uncertainty interval 473 000 – 789 000). An estimated 3.4 billion people continue to be at risk of malaria, mostly in Africa and south-east Asia. Around 80% of malaria cases occur in Africa.

The “World malaria report 2013” summarizes information received from 102 countries that had on-going malaria transmission during the 2000-2012 period, and other sources, and updates the analyses presented in 2012.

The report contains revised estimates of the number of malaria cases and deaths, which integrate new and updated under-5 mortality estimates produced by the United Nations Inter-agency Group for Child Mortality Estimation, as well as new data from the Child Health Epidemiology Reference Group.

http://www.who.int/mediacentre/news/releases/2013/world-malaria-report-20131211/en/index.html

From the report:
5.3 New therapies for malaria prevention
5.3.1 Malaria vaccine development
An effective vaccine against malaria has long been envisaged as a valuable addition to the available tools for malaria control. Although research towards the development of malaria vaccines has been pursued since the 1960s, as yet there are no licensed malaria vaccines.  However, a number of candidate vaccines are being evaluated in clinical trials, with one candidate vaccine currently being assessed in Phase 3 clinical trials (RTS,S/AS01) (8), and about 20 others in Phase 1 or Phase 2 clinical trials.5

Vaccine candidate RTS,S/AS01
The RTS,S/AS01 vaccine targets P. falciparum. Now in Phase 3 clinical trials, the vaccine is being developed in a partnership between GlaxoSmithKline (GSK) and PATH Malaria Vaccine

Initiative (MVI), with MVI receiving funds from the Bill & Melinda Gates Foundation. The vaccine comprises a fusion protein of a malaria antigen – the carboxy terminus of the P. falciparum

circumsporozoite (CS) antigen – with hepatitis B surface antigen, and includes a new and potent adjuvant. The manufacturer’s clinical development plan for the vaccine focuses on infants and young children living in malaria-endemic African countries.

In October 2013, a third set of results on the efficacy of the RTS,S/AS01 vaccine were reported for 6–14 week and 5–17 month age groups (9). In the 5–17 month age group, efficacy estimates, pooled across all trial sites, remained statistically significant against clinical malaria (46%) and severe malaria (35.5%).

Reductions in both malaria hospitalizations (41.5%) and all-cause hospitalizations (19%) were noted over 18 months. By contrast, at 27% in the 6–14 week age group, the efficacy estimate for severe malaria was not statistically significant (although efficacy against clinical malaria remained statistically significant). In the 5–17 month age group, site-specific efficacy was demonstrated in all 11 settings in seven African countries. The site-specific efficacy estimates over 18 months of follow-up ranged from 40% to 77%, with statistical significance at all sites.    By contrast, statistically significant efficacy was confirmed at four of the 11 sites in the younger 6–14 week age group. The reasons for this difference between the age groups are unclear, but co-administration with DTP-containing vaccines and the presence of maternally acquired antibodies to malaria may contribute to a lower immune response in infants aged 6–14 weeks.

The full Phase 3 trial results will become available to WHO in late 2014 and will include 30 months of follow-up safety and efficacy data from groups of children aged 6–14 weeks and

5–17 months, together with data on efficacy and safety of an 18-month booster dose and site-specific efficacy. The WHO Joint Technical Expert Group on Malaria Vaccines (together with the Global Malaria Programme and Department of Immunization, Vaccines and Biologicals), has advised that, in the light of the results published to date, a policy recommendation could be considered once the full trial results become available. The timelines of the Phase 3 trial may allow a WHO review and recommendation in late 2015, as a potential addition to the current WHO-recommended malaria preventive measures. The WHO process for review will also depend on the timings and outcome of the regulatory review that will be performed by the European Medicines Agency in 2014–2015.

Any possible recommendation related to vaccination in the 5–17 month age group would require at least two visits to be added to the routine immunization schedule.

   Other malaria vaccine candidates in development
Several other vaccine candidates are currently being explored, but their development is at least 5–10 years behind that of RTS,S/AS01. Details are provided in The Rainbow Tables: WHO’s comprehensive spreadsheets of global malaria vaccine project activity, which are updated every 6 months. In November 2013, WHO and the malaria vaccine funders group launched an update to the Malaria Vaccine Technology Roadmap,6 with two new strategic goals. These goals are the development of highly efficacious vaccines to prevent malaria disease and deaths, and of vaccines designed to interrupt malaria transmission and contribute towards the long-term aim of malaria eradication. The revised goals also expand the roadmap to include P. vivax as well as P. falciparum…